The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular l...
FDA Recall #Z-2571-2025 — Class II — August 29, 2025
Product Description
The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
Reason for Recall
The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk Group 3 (high risk) in about 2.2 minutes). The product has a radiation safety defect, in that these radiation emissions are unnecessary to the accomplishment of the product s primary purpose of disinfecting objects and surfaces, and create a risk of skin and/or eye injuries to user and nearby persons.
Recalling Firm
BigTree Sales Inc. — Arcadia, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
N/A
Distribution
U.S.A
Code Information
SKU BT-GERMWAND-LRG-WHT and Testing: September 8-10, 2020
Status
Ongoing
Voluntary / Mandated
FDA Mandated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.